MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number FLIPCUTTER II, SHORT 9MM

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during anterior cruciate ligament surgery the tube of the flipcutter did become loose and broke apart into two pieces while drilling the tibial drill channel.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-1204as-90 actuator tube was received for investigation.The handle assembly was not returned for analysis.Visual inspection identified that the cutting tip was intact, although surface damage was noted across the blades.Circumferential damage was present across the actuator tube.The breakage site at the proximal end of the tube was noticeably warped.The observed condition is most likely the result of breakage at the weld between the handle and the actuator tube during use via user applied mechanical forces through prying/leveraging.

• Brand Name: FLIPCUTTER II, SHORT 9MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12198476
• MDR Text Key: 264738148
• Report Number: 1220246-2021-03424
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004436
• UDI-Public: 00888867004436
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLIPCUTTER II, SHORT 9MM
• Device Catalogue Number: AR-1204AS-90
• Device Lot Number: 0041101217
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2021
• Patient Sequence Number: 1